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IRCT20100124003146N8 IRCT 2019-10-19 Kashan University of Medical Sciences The effect of rewarming on hemodynamic parameters and cognitive state in patients after open heart surgery Study of the effect of rewarming on hemodynamic parameters and cognitive state in patients after open heart surgery 2019-08-21 anticipated 80 Complete https://irct.ir/trial/40697 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Samples were randomly assigned to experimental and control groups by block randomization (via software) with 4 blocks, Blinding description: Because patients have low level of consciousness and are intubated, they are not aware of the type of intervention and are blind. On the other hand, the person who analyzes the results of the study is not aware of the intervention or control group. N/A Hemodynamic parameters of the patient undergoing open heart surgery- cognitive state of the patient undergoing open heart surgery. Intervention 1: Intervention group: Use of a warm mattress at the time of entering the patient to intensive care unit until the body temperature reaches 37 ° C after open heart surgery.in this method , for warming the patient, E U 133 (Electric Under blanket with heating) will be used which has the power of W75. the size of the product is about 150* 80 cm . temperature setting has three level index , which is switched off automatically after three hours , warms fast and the most heat is in the foot. Intervention 2: Control group: control group will receive the routine care after open heart surgery. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no more information.
public Esmail Azizi
Ravand Ave., Parastar Blvd.
Kashan Iran (Islamic Republic of) 8715981151 +98 31 5554 0022 azizi_es@kaums.ac.ir Kashan University of Medical Sciences scientific Ismail Azizi-Fini
Ravand Ave., Parastar Blvd.
Kashan Iran (Islamic Republic of) 8715981151 +98 31 5554 0022 azizi_es@kaums.ac.ir Kashan University of Medical Sciences Iran (Islamic Republic of) Having informed consent for participating in study Gaining MMSE score of more than 24 at the beginning of the study Patients candidate for elective Open-Heart surgery Not having Intra-Aortic Balloon Pump before the surgery no limit no limit Both Prolongation of intubation (more than 12 hours) for respiratory problems Opened chest for postoperative reasons Having Intra-Aortic Balloon Pump after the surgery post-operative re-intubation Patients who underwent the surgery of aneurysm or dissection of aorta patient death Return to operating room for any reason Prolonged surgery for more than 5 hours Patients undergoing emergency open heart surgery Treatment - Devices N/A Intervention group: Use of a warm mattress at the time of entering the patient to intensive care unit until the body temperature reaches 37 ° C after open heart surgery.in this method , for warming the patient, E U 133 (Electric Under blanket with heating) will be used which has the power of W75. the size of the product is about 150* 80 cm . temperature setting has three level index , which is switched off automatically after three hours , warms fast and the most heat is in the foot Control group: control group will receive the routine care after open heart surgery. Mean arterial pressure. Timepoint: Before the intervention at the time of entering of the patient to the ICU, every 30 minutes (at the first hour of intervention), every hour (for 4 hours after the intervention). Method of measurement: monitor. Systolic blood pressure. Timepoint: Before the intervention at the time of entering of the patient to the ICU, every 30 minutes (at the first hour of intervention), every hour (for 4 hours after the intervention). Method of measurement: monitor. Diastolic blood pressure. Timepoint: Before the intervention at the time of entering of the patient to the ICU, every 30 minutes (at the first hour of intervention), every hour (for 4 hours after the intervention). Method of measurement: monitor. Central venous pressure. Timepoint: Before the intervention at the time of entering of the patient to the ICU, every 30 minutes (at the first hour of intervention), every hour (for 4 hours after the intervention). Method of measurement: monitor. Heart rate. Timepoint: Before the intervention at the time of entering of the patient to the ICU, every 30 minutes (at the first hour of intervention), every hour (for 4 hours after the intervention). Method of measurement: monitor. Temperature. Timepoint: Before the intervention at the time of entering of the patient to the ICU, every 30 minutes (at the first hour of intervention), every hour (for 4 hours after the intervention). Method of measurement: temperature probe of monitor. Urine output. Timepoint: Before the intervention at the time of entering of the patient to the ICU, every hour (for 4 hours after the intervention). Method of measurement: urinary bag. Drainage. Timepoint: Before the intervention at the time of entering of the patient to the ICU, every hour (for 4 hours after the intervention). Method of measurement: Drainage bottle. Cognitive state. Timepoint: Before the intervention and one week after surgery. Method of measurement: MMSE questionnaire. Kashan University of Medical Sciences Approved 2019-07-01 Ethics committe of Kashan University of Medical Sciences 5th kilometer Qotb Ravandi blouvar Kashan Isfehan Iran (Islamic Republic of)